A Food Effect Study to Evaluate the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy Participants

Recruiting now · Phase 1

Conditions studied: Healthy Participants

In brief

The primary purpose of this study is to evaluate the effect of a high-fat, high-calorie meal on the relative bioavailability of NAL ER following single oral doses.

Key facts

Study ID

NCT07487740

Run by

Trevi Therapeutics

People needed

60

Starts

2026-02-27

Expected to finish

2026-04-01

Last updated by the study team

2026-03-23

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kilogram per meter square (kg/m2) at Screening.
• Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), as deemed by the principal investigator (PI) or designee.

You may not qualify if…

• Positive results for coronavirus infection (COVID-19) at Screening or check-in (Day -1).
• History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.
• Positive urine drug or alcohol results at Screening or check in (Day -1).
• Smoker who has smoked or used nicotine containing products within the last 3 months prior to the first dose and throughout the study, confirmed by a negative cotinine test at Screening and check-in (Day -1).
• History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
• Hemoglobin, absolute neutrophil count, or platelet levels outside of the reference range at Screening.
• History of prolonged QT syndrome or a corrected QT (QTc) interval.
• Positive results at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
• Participation in another clinical study within 5 half-lives or 30 days, whichever is longer, of the Baseline visit.
• Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.

Where it is running

• Clinical Pharmacology of Miami, LLC. — Miami, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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